UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 23, 2019
HTG Molecular Diagnostics, Inc.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-37369 |
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86-0912294 |
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(State or other jurisdiction of incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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3430 E. Global Loop Tucson, AZ |
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85706 |
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(Address of principal executive offices) |
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(Zip Code) |
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Registrant’s telephone number, including area code: (877) 289-2615
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 ( § 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 ( § 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒
On April 23, 2019, HTG Molecular Diagnostics, Inc. (the “Company”) and Illumina, Inc. (“Illumina”) entered into the First Amendment to Amended and Restated IVD Test Development and Component Supply Agreement (the “First Amendment”), effective as of April 3, 2019. The First Amendment amends the Amended and Restated IVD Test Development and Component Supply Agreement, effective May 31, 2017 (the “Agreement”), which initially amended and restated the parties’ IVD Test Development and Component Supply Agreement entered into in October 2014.
The Company and Illumina entered into the Agreement to provide for the development and worldwide commercialization by the Company of nuclease-protection-based RNA or DNA profiling tests (“IVD test kits”) for use with Illumina’s MiSeqDx sequencer in the field of diagnostic oncology testing in humans (the “Field”).
The First Amendment expands the scope of the Field to include diagnostic testing in humans for (i) autoimmune disorders and diseases, (ii) cardiovascular disorders and diseases, and (iii) fibrosis disorders and diseases ((i)-(iii) together, the “Other Fields”). The Company and Illumina will continue the development plans that have been previously entered into under the Agreement, and the Company may, at its discretion, submit additional development plans for IVD test kits in the Field to Illumina for its approval, not to be unreasonably withheld. Illumina will consider requests for additional development plans for IVD test kits in the Other Fields in good faith but may accept or reject any such requests in its sole and absolute discretion.
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Date: April 29, 2019 |
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HTG Molecular Diagnostics, Inc. |
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By: |
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/s/ Shaun D. McMeans |
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Shaun D. McMeans |
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Senior Vice President and Chief Financial Officer |